New Drug Could Reduce Tissue Damage After Heart Attack

A study led by UCL (University College London) scientists has designed a new drug that inhibits the adverse effects of C reactive protein (CRP), a protein that contributes to tissue damage in heart attacks and strokes. The findings, published in the journal Nature, suggest that targeting CRP may produce both immediate and long-term clinical benefits following a heart attack.

CRP is normally present at trace levels in the blood but its concentration increases sharply in almost all diseases including trauma, infection, strokes and chronic illnesses such as rheumatoid arthritis and Crohn's disease. CRP levels also rise dramatically after a heart attack. Patients with the greatest and most persistent increases in CRP concentration suffer higher mortality, and CRP is always deposited in and around the damaged heart tissue.

Inflammation contributes significantly to the extent of heart attack damage and this can be exacerbated by CRP. The UCL team has previously shown that human CRP increases the severity of damage in experimental models of heart attack and stroke. This first identified CRP as a valid therapeutic target. The present collaborative study has now rationally designed a potent small molecule inhibitor of CRP.

The new compound, bis(phosphocholine)-hexane, is bound by CRP, inhibits all CRP functions in the test tube, and blocks the tissue damaging effect of CRP in an experimental heart attack model.

Professor Mark Pepys, of the UCL Centre for Amyloidosis and Acute Phase Proteins, whose work on CRP has been supported by the Medical Research Council since 1979, says: "Although heart attacks are responsible for about one third of all deaths in developed countries, most patients survive a first heart attack. However, if they have a large scar, patients go on to develop heart failure which is eventually fatal. Reducing the immediate damage is thus critically important.

"We had previously invented a new mechanism of drug action for small molecules bound by target proteins. Coupled with knowledge of the structure and properties of CRP, we were able to design the CRP inhibitor.

"We now propose to develop a CRP inhibitor as rapidly as possible for testing in patients with heart attacks.

"The drug would be given as soon as patients arrived in hospital. If effective, it would reduce the amount of damage in the heart, thus limiting both early mortality and the size of the scar left in the heart.

"Provided adequate support is available, it should be possible to undertake clinical trials of CRP inhibition within a couple of years. If the treatment proves safe and effective, we also aim to investigate its effectiveness in strokes.

"It is likely that CRP contributes to tissue damage in a range of diseases in which CRP levels are greatly increased, and the inhibition of CRP may thus find broad application in medicine."

Patents, patent applications and proprietary knowledge related to this work are owned by Pentraxin Therapeutics Ltd, a UCL spin out company of which Professor Pepys is director.

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Contact: Jenny Gimpel
University College London

Women Under 60 Appear To Be At Increased Risk For Depression After Heart Attack

Women age 60 years or younger are more likely than other patients to be depressed during hospitalization for heart attack, according to a study in the April issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Depression is common in patients with cardiovascular disease, including acute myocardial infarction (heart attack), according to background information in the article. Depressed heart attack patients are more likely to be hospitalized and die of heart problems and tend to have worse health and higher health care costs than heart attack patients who are not depressed. Identifying patients who are likely to be depressed after heart attack could help physicians screen and treat those at highest risk.

Susmita Mallik, M.D., M.P.H., Emory University School of Medicine, Atlanta, and colleagues assessed the prevalence of depression in 2,498 patients who were hospitalized with acute myocardial infarction between January 2003 and June 2004 at one of 19 study sites across the United States. The 814 women and 1,684 men were interviewed during their hospitalization and asked how often they experienced each of nine symptoms of depression. For each patient, researchers compiled an overall depression score between zero and 27 by adding up points for each answer--from zero for each symptom that bothered the patient "not at all" to three for each that he or she experienced "nearly every day." Individuals with a score of 10 or higher were classified as depressed. Participants' medical records also were thoroughly reviewed.

Patients were interviewed an average of 2.9 days after they arrived at the hospital. About 22 percent of all the participants were depressed, and those who were depressed had more associated illnesses, were in poorer health and were more likely to have a history of heart problems and diabetes than those who were not. Women and younger patients (age 60 years or younger) were more likely to be depressed than men and older patients, with younger women at highest risk. The prevalence of depression was 40 percent in women age 60 years or younger, 21 percent in women older than 60, 22 percent in men 60 or younger and and 15 percent in men older than 60. In additional analysis in which other factors were considered, the odds of depression were three times higher for women age 60 years and younger than for men older than age 60 years.

Researchers are not sure why younger women are most likely to be depressed after heart attack, but the authors suggest that hormones and social pressures may contribute to their increased risk. "Differential sex roles and exposure to social and environmental stressors, such as poverty, lower level of education, responsibilities both at work and home, single parenthood and caring for children and aging parents, could theoretically contribute to a higher preponderance of depression in younger women, who may have greater exposure to these stressors compared with other groups," they write.

These findings also suggest that depression may be part of the reason that younger women are more likely than younger men to have complications or die after heart attack, although further study is needed to evaluate this connection. Either way, younger women may benefit from more aggressive screening and treatment of depression after heart attack, the authors conclude.

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(Arch Intern Med. 2006; 166: 876-883)

This study was supported by the Emory University General Clinical Research Center, Atlanta, Ga., and by a grant from CV Therapeutics, Palo Alto, Calif. Please see study for full financial disclosures from authors.

Contact: Holly Weaver Korschun
JAMA and Archives Journals

Low Intake Of Milk In Pregnancy Associated With Decreased Birth Weight

Women increasingly self-restrict milk intake during pregnancy, for a variety of reasons. Does this have an effect on their infants' birth weight?

In this study, women whose daily consumption of milk during pregnancy was 1 cup (250 ml) or less consumed less protein and vitamin D and gave birth to smaller babies than mothers who drank more milk. Milk and vitamin D intakes during pregnancy were found to be each associated with infant birth weights, independently of other risk factors.

In a related commentary, Hollis and Wagner note that this study makes a very intriguing and important observation in relation to vitamin D. They believe that vitamin D may not only affect fetal skeletal formation, but also neurodevelopment, immune function and chronic disease susceptibility later in life.

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p.1273 Association of low intake of milk and vitamin D during pregnancy with decreased birth weight
-- C.A. Mannion et al
http://www.cmaj.ca/pressrelease/pg1273.pdf

1287 Nutritional vitamin D status during pregnancy: reasons for concern
-- B.W. Hollis, C.L. Wagner
http://www.cmaj.ca/pressrelease/pg1287.pdf

Contact: Dr. Kristine Koski
Canadian Medical Association Journal

Cialis Is Effective In The Treatment Of Men With Erectile Dysfunction Regardless Of Previous Effective Viagra Use

UroToday.com - The phosphodiesterase type 5 (PDE-5) inhibitors have revolutionized the pharmacologic management of erectile dysfunction (ED). Viagra (sildenafil citrate) was the first of the class to be introduced in 1998 and later followed by Levitra (Vardenafil) and Cialis (Tadalafil) in 2003. Therefore, men currently taking Cialis‚ may have had previous experience with Viagra‚. Because of the unique properties of each drug, many patients will try more than one of these agents.

Dr. Broderick of the Mayo clinic in Jacksonville, Florida and colleagues recently reviewed 14 placebo controlled, double-blinded trials of Cialis‚ use in men who were either previous Viagra‚ responders or naïve to the PDE-5 class of medications. A total of almost 2800 men were analyzed for this study. Patients who failed to have an erectile response to Viagra‚ were excluded from this analysis.

The investigators found that Cialis‚ at 10 or 20 mg improved erectile function over placebo regardless of previous Viagra use or PDE-5 inhibitor naive patients. Conclusions were based on results measured by the International Index of Erectile Function (IIEF) EF domain score, Sexual Encounter Profile (SEP) questions Q2 (successful penetration) and Q3 (successful intercourse) and a Global Assessment Question (GAQ1) about erectile improvement.

By Raymond Pak, MD

Editorial Comment: Conducting a clinical trial in the post-Viagra clinical era is difficult. Most trials exclude patients who have tried and failed to respond to Sildenafil citrate, leaving the patient population as those men who may have tried and been successful with sildenafil or those that have never tried any phophodiesterase type 5 inhibitor. An automatic criticism is that this patient population is enhanced, with potential failures screened out from the very beginning. There is no doubt that whether or not men entering clinical trials have tried Viagra or not, their expectations are different from men volunteering for clinical trials in ED prior to 1998. Expectations are an important factor even in placebo controlled trials. The above clinical trial suggests that Cialis when administered to two groups of men (prior successful Sildenafil use and Sildenafil naïve patients) is equally effective. The study was not designed to suggest or conclude that Cialis is more effective than Sildenafil.

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

Copyright © 2006 - UroToday

Scientists Develop New Concept With Potential To Help Predict How Individuals May Respond To Drugs

Scientists from Imperial College London and Pfizer have developed a new method that could predict individual patient responses to drug treatments. The authors anticipate that the development will advance biomedical research further towards development of personalised medicines.

Research published today in Nature demonstrates the new 'pharmaco-metabonomic' approach that uses a combination of advanced chemical analysis and mathematical modelling to predict drug-induced responses in individual patients. The method is based on analysis of the body's normal metabolic products, metabolites, and metabolite patterns that are characteristic of the individual. The authors hypothesize that these individual patterns can be used to diagnose diseases, predict an individual's future illnesses, and their responses to treatments.

Not all drugs are effective in all patients and in rare cases adverse drug reactions can occur in susceptible individuals. To address this, researchers from Imperial College and Pfizer have been exploring new methods for profiling individuals prior to drug therapy. The new approach, if successful, requires the analysis of the metabolite profiles of an individual from a urine, or other biofluid, sample.

The researchers tested their approach by administering paracetamol to rats and measuring how it affected their livers and how it was excreted. Before giving the dose they measured the levels of the natural metabolites in the rats' urine. Metabolites being small molecules produced by normal body functions, they can indicate a body's drug response. After creating a 'pre-dose urinary profile' for each rat, the researchers used computer modelling to relate the nature of the pre-dose metabolite profile to the nature of the post-dose response.

Professor Jeremy Nicholson, from Imperial College London, who led the research, says: "This new technique is potentially of huge importance to the future of healthcare and the pharmaceutical industry. The 'pharmaco-metabonomic' approach is able to account for genetic as well as many environmental factors, and other important contributors to individual health such as the gut microfloral activity. These factors strongly influence how an individual absorbs and processes a drug and also influence their individual metabolism, making this new approach the first step towards the development of more personalised healthcare for large numbers of patients."

The discovery of this new technology for predicting responses to drugs, which is not limited to individual genetic differences, will hopefully be a key component in the pharmaceutical industry's aim to understand how patients might benefit from more individualised therapies. The new method is expected to be synergistic with existing pharmacogenomic approaches.

The new methodology is in early stage of development and will be studied in humans to evaluate its possible clinical application. The researchers hope this new technique might one day allow doctors to personalise drug treatments for some individuals, providing physicians with the ability to prescribe medicines that will be most effective for certain patient groups, and at a tailored dose-range for maximum efficacy and safety.

###

Contact: Tony Stephenson
at.stephenson@imperial.ac.uk
Imperial College London

Preconception Health Care Can Improve The Lives Of Mothers And Babies

Every visit to the doctor for women of childbearing age should be considered an opportunity to discuss reproductive health - especially since more than half of all pregnancies are unintended, according to a report published today in the U.S. Centers for Disease Control and Prevention's journal Morbidity and Mortality Weekly Report Recommendations and Reports.

Making preconception health care part of routine medical visits can help identify risk factors for pregnancy complications and adverse birth outcomes, allowing doctors to offer women additional services to reduce the risk of premature birth and birth defects to help give their future babies a healthy start in life.

"We could do much more to improve the health of mothers and babies if we could identify risk factors before pregnancy and educate women about what health changes they can make," said Janis Biermann, co-author of the study and vice president for Education and Health Promotion of the March of Dimes. "For some of these problems, the preconception period, or the time between pregnancies, is the only chance to make a difference."

Ms. Biermann says providing care before a woman becomes pregnant is crucial because many factors that can harm fetal development do serious damage early in pregnancy, often before a woman realizes she is pregnant.

For example, women can be told of the dangers to the fetus of smoking and drinking alcohol during pregnancy, and informed of the benefits of taking folic acid to reduce the risk of serious birth defects. Chronic diseases such as diabetes, asthma and high blood pressure can be diagnosed and managed, allowing the mother to maintain good health while protecting the health of her future children. Medications may need to be changed to maximize the chance of a healthy baby.

Recommendations to Improve Preconception Health and Health Care was published in Volume 55, No. RR-6 of the CDC's MMWR (April 2006)

The recommendations are:

1. Encourage everyone to have a reproductive life plan.
2. Increase public awareness about preconception health.
3. Provide risk assessment and counseling during primary care visits.
4. Increase the number of women who receive interventions after risk screening.
5. Use the time between pregnancies to provide intensive interventions to women who have had a pregnancy that resulted in infant death, low birthweight or premature birth.
6. Offer one pre-pregnancy visit.
7. Increase health insurance coverage among low-income women.
8. Integrate preconception health objectives into public health programs
9. Augment research.
10. Maximize public health surveillance.

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The March of Dimes works to improve the health of babies by preventing birth defects, premature birth and infant mortality. For more information, visit marchofdimes.com or nacersano.org for Spanish.

Contact: Elizabeth Lynch
March of Dimes Birth Defects Foundation

Analysis Highlights Areas For Research Into Genetic Causes Of Alcoholism

The findings of a meta-analysis of microarray data of several mouse models that differ in voluntary alcohol consumption highlight new neurobiological targets for further study and provide researchers a novel statistical approach for use in future microarray meta-analyses.

Insight into the genetic differences in gene expression associated with different levels of drinking may lead to a better understanding of alcoholism. Genetic studies of alcoholism have long confirmed the complexity of the disease and uncovering the underlying molecular mechanisms remains a formidable task.

The meta-analysis was completed by Susan Bergeson, an assistant professor of neurobiology at The University of Texas at Austin, and a multi-site research team participating in a National Institute on Alcohol Abuse and Alcoholism supported Integrative Neuroscience Initiative on Alcoholism (INIA). It has led to new insights into the genetics of the predisposition to drink alcohol.

"What our results do is essentially generate candidate genes to be tested," Bergeson said. "Many of the genes we identified have never previously been implicated in alcohol drinking, including several whose function remains completely unknown."

The analysis involved nine mouse models, which differed in their levels of alcohol consumption. None of the mice were exposed to alcohol because the focus of the experiment was to study the genetic predisposition to drink alcohol.

Gene expression in the brain was assayed using microarray analysis, and a novel statistical approach to the meta-analysis identified nearly 4,000 differentially regulated genes between the high and low alcohol consuming mice.

The INIA investigators narrowed the significant changes using three different approaches:

An overlap analysis between human and mouse was completed using chromosomal regions shown to be associated with drinking and alcohol dependence in previously reported genetic studies. Thirty-three genes in the meta-analysis matched these regions where the human and mouse genetic alignments are the same; 11 were from three gene families.

In addition, the thousands of genes were narrowed to a much shorter list using bioinformatics approaches that identified overrepresentation within pathways.

Finally, 20 genes for one chromosomal region long been known to be involved in alcohol drinking were identified using a novel filtering approach.

Mice containing a chromosome 9 region from a low alcohol drinking strain in the genome of a high alcohol drinking strain were also analyzed. Microarray results for the congenic 9 mouse became a filter for the overall meta-analysis and were used to identify genetically divergent genes on mouse chromosome nine.

"We were able to use the power of many studies to narrow thousands of candidate genes to a manageable list in a way that would have been considerably more difficult without the meta-analysis," Bergeson said. "In addition, there were several genes found associated with drinking in this study that have never previously been characterized. If we had done nothing else but point to a gene that would have not been otherwise discovered, that was a valuable thing to do." Blednov, Vishwanath R. Iyer and Bergeson of The University of Texas at Austin.

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The findings were published in the online early edition of the Proceedings of the National Academy of Sciences.

Researchers participating in the study: Robert J. Hitzemann, John K. Belknap, John C. Crabbe, Tamara J. Phillips and Deborah A. Finn of the Oregon Health & Science University; Boris Tabakoff and Paula L. Hoffman of the University of Colorado Health Sciences Center; Nicholas J. Grahame of Indiana University-Purdue University at Indianapolis; George F. Koob of the Scripps Research Institute, San Diego; and Megan K. Mulligan, Igor Ponomarev, , R. Adron Harris, Yuri A.

Contact: Tim Green
timgreen@mail.utexas.edu

University of Texas at Austin

New Genes For Excessive Alcohol Drinking Discovered

Researchers supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health (NIH), have identified new genes that may contribute to excessive alcohol consumption. The new study, conducted with strains of animals that have either a high or low innate preference for alcohol, provides clues about the molecular mechanisms that underlie the tendency to drink heavily. A report of the findings appears in the April 2006 issue of Proceedings of the National Academy of Sciences.

"These findings provide a wealth of new insights into the molecular determinants of excessive drinking, which could lead to a better understanding of alcoholism," notes NIAAA Director Ting-Kai Li, M.D. "They also underscore the value that animal models bring to the investigation of complex human disorders such as alcohol dependence."

Mice that have been selectively bred to have either a high or low preference for alcohol have been a mainstay of alcohol research for many years, allowing investigators to study diverse behavioral and physiological characteristics of alcohol dependence. In the current study, NIAAA grantee Susan E. Bergeson, Ph.D., of the University of Texas (UT) at Austin, and a multi-site team of scientists participating in NIAAA's Integrative Neuroscience Initiative on Alcoholism (INIA) used microarray techniques to study gene expression in the brains of these animals. Microarrays are powerful tools that investigators use for comprehensive analyses of gene activity.

"Microarrays allow us to look at the full complement of genes that are active in the brains of animals bred to exhibit very different alcohol drinking behaviors," said Dr. Bergeson, an Assistant Professor of Neurobiology in UT's Waggoner Center for Alcohol and Addiction Research. When a gene is activated, cellular machinery transcribes certain parts of the gene's DNA into messenger RNA (mRNA), which is the body's template for creating proteins. The complete set of transcribed mRNA in a tissue is termed the "transcriptome."

Dr. Bergeson and her INIA colleagues examined brain transcriptomes of nine strains of mice, each differing in their voluntary alcohol consumption.

"By measuring total gene expression in brains of each of the mouse models we could explore which transcripts are consistently changed in different genetic models of high and low alcohol intake and thereby define the transcriptional signatures of genetic predisposition to high and low alcohol consumption," said Dr. Bergeson.

The researchers employed novel statistical techniques to identify nearly 4,000 differentially expressed genes between the high and low alcohol drinking mouse strains and to narrow the focus to 75 primary candidate genes. In addition, a comparison of the mouse data with human genetic studies revealed that genes with significant expression differences reside in chromosomal regions that previously were shown to be associated with human alcoholism.

Numerous pathways, as well as genes whose functions are currently unknown, may contribute to the genetic predisposition to drink high amounts of alcohol, notes Dr. Bergeson. "Our results will allow us to begin to focus on targets never previously implicated in excessive drinking. For example, genetic studies have shown that chromosome 9 contains genes that may regulate alcohol consumption in mice. Our analyses allowed us to narrow our focus from thousands of genes in that region to twenty."

"This first microarray-based analysis of a behavioral trait reveals many new research opportunities and exemplifies the rich collaborative potential of NIAAA's INIA consortium," adds Dr. Li.

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The National Institute on Alcohol Abuse and Alcoholism, part of the National Institutes of Health, is the primary U.S. agency for conducting and supporting research on the causes, consequences, prevention, and treatment of alcohol abuse, alcoholism, and alcohol problems and disseminates research findings to general, professional, and academic audiences. Additional alcohol research information and publications are available at http://www.niaaa.nih.gov/.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

Reference: Mulligan, MK, et al. Toward Understanding the Genetics of Alcohol Drinking Through Transcriptome Meta-analysis, Proceedings of the National Academy of Sciences 2006 103/16: 6368-6373.

Contact: John Bowersox
jbowersox@mail.nih.gov
NIH/National Institute on Alcohol Abuse and Alcoholism

Raloxifene Reduces Breast Cancer Risk As Well As Tamoxifen

A study called STAR, Study of Tamoxifen and Raloxifene has shown, according to initial results, that Raloxifene is as effective as Tomoxifen in the prevention of invasive breast cancer among women who have a higher risk of the disease. Raloxifene is currently used to treat and prevent osteoporosis in postmenopausal women.

(STAR = Study of Tamoxifen And Raloxifene)

Both Tamoxifen and Raloxifene lowered the risk of invasive breast cancer by approximately 50%.

Raloxifene had other protective benefits. Women who were prospectively and randomly assigned to take Raloxifene each day and were monitored for four years, when compared to women on Tamoxifen:

-- Had 36% fewer uterine cancers
-- 29% fewer blood clots

Tamoxifen and Raloxifene raise a woman's risk of developing blood clots.

The study looked at 19,474 postmenopausal women who had higher risk of developing invasive breast cancer. Some of the women were given 60mg of Raloxifene, others were given 20mg of Tamoxifen for a period of five years - selection was random.

The study is funded by the NCI (National Cancer Institute).

John E. Niederhuber, M.D., who is currently providing leadership at NCI, said "This optimistic news from STAR is a significant step in breast cancer prevention. These results, once again, demonstrate the critical importance of clinical trials in our efforts to establish evidence-based practices."

So, it seems Raloxifene is just as affective as Tamoxifen, without the level of serious side-effects Tamoxifen has. There are also indications that Raloxifene, unlike Tamoxifen, does not raise a woman's risk of developing a cataract.

The women in this trial are now being told which of the two drugs they were on. Those on Raloxifene can continue with the same treatment until the five years are concluded. Those on Tamoxifen can chose to switch to Raloxifene.

Study of Tamoxifen and Raloxifene (STAR) Trial

Written by: Christian Nordqvist
Editor: Medical News Today

Vegan Diets Healthier For Planet, People Than Meat Diets

The food that people eat is just as important as what kind of cars they drive when it comes to creating the greenhouse-gas emissions that many scientists have linked to global warming, according to a report accepted for publication in the journal Earth Interactions.

Both the burning of fossil fuels during food production and non-carbon dioxide emissions associated with livestock and animal waste contribute to the problem, the University of Chicago's Gidon Eshel and Pamela Martin wrote in the report.

The average American diet requires the production of an extra ton and a half of carbon dioxide-equivalent, in the form of actual carbon dioxide as well as methane and other greenhouse gases compared to a strictly vegetarian diet, according to Eshel and Martin. And with Earth Day approaching on April 22, cutting down on just a few eggs or hamburgers each week is an easy way to reduce greenhouse-gas emissions, they said. "We neither make a value judgment nor do we make a categorical statement," said Eshel, an Assistant Professor in Geophysical Sciences.

"We say that however close you can be to a vegan diet and further from the mean American diet, the better you are for the planet. It doesn't have to be all the way to the extreme end of vegan. If you simply cut down from two burgers a week to one, you've already made a substantial difference."

The average American drives 8,322 miles by car annually, emitting 1.9 to 4.7 tons of carbon dioxide, depending on the vehicle model and fuel efficiency. Meanwhile, Americans also consume an average of 3,774 calories of food each day.

In 2002, energy used for food production accounted for 17 percent of all fossil fuel use in the United States. And the burning of these fossil fuels emitted three-quarters of a ton of carbon dioxide per person. That alone amounts to approximately one-third the average greenhouse-gas emissions of personal transportation. But livestock production and associated animal waste also emit greenhouse gases not associated with fossil-fuel combustion, primarily methane and nitrous oxide.

"An example would be manure lagoons that are associated with large-scale pork production," Eshel said. "Those emit a lot of nitrous oxide into the atmosphere."

While methane and nitrous oxide are relatively rare compared with carbon dioxide, they are--molecule for molecule--far more powerful greenhouse gases than carbon dioxide. A single pound of methane, for example, has the same greenhouse effect as approximately 50 pounds of carbon dioxide.

In their study, Eshel and Martin compared the energy consumption and greenhouse-gas emissions that underlie five diets: average American, red meat, fish, poultry and vegetarian (including eggs and dairy), all equaling 3,774 calories per day.

The vegetarian diet turned out to be the most energy-efficient, followed by poultry and the average American diet. Fish and red meat virtually tied as the least efficient.

The impact of producing fish came as the study's biggest surprise to Martin, an Assistant Professor in Geophysical Sciences. "Fish can be from one extreme to the other," Martin said. Sardines and anchovies flourish near coastal areas and can be harvested with minimal energy expenditure. But swordfish and other large predatory species required energy-intensive long-distance voyages.

Martin and Eshel's research indicated that plant-based diets are healthier for people as well as for the planet.

"The adverse effects of dietary animal fat intake on cardiovascular diseases is by now well established. Similar effects are also seen when meat, rather than fat, intake is considered," Martin and Eshel wrote. "To our knowledge, there is currently no credible evidence that plant-based diets actually undermine health; the balance of available evidence suggests that plant-based diets are at the very least just as safe as mixed ones, and most likely safer."

In their next phase of research, Eshel and Martin will examine the energy expenditures associated with small organic farms, to see if they offer a healthier planetary alternative to large agribusiness companies. Such farms typically provide the vegetables sufficient to support 200 to 300 families on plots of five to 10 acres.

"We're starting to investigate whether you can downscale food production and be efficient that way," Martin said.

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Contact: Steve Koppes
skoppes@uchicago.edu
University of Chicago

Folic Acid Important In Woman's Diet

Most women do not get enough folic acid in their diet to help protect their babies from life-threatening birth defects like spina bifida, which recently gained national attention when the afflicted Iraqi Baby Noor was taken to Georgia for surgery.

Folic acid, a B vitamin, can prevent up to 70 percent of some serious birth defects of a baby's brain or spine. Unfortunately, most women are unaware how important the vitamin is for both themselves and their babies. And, to prevent birth defects, it must be taken daily before pregnancy.

“Neural tube defects are the second most common serious birth defect,” said Laura Mitchell, Ph.D., principal investigator for the Spina Bifida Research Resource at the Texas A&M Health Science Center Institute of Biosciences and Technology in Houston. “The neural tube develops very early in pregnancy, often before a woman realizes she is pregnant. But, in some instances, women are still not aware of the need to take folic acid before conception, and in other cases, women feel they have a healthy diet and do not need to take a supplement.”

Further, folic acid is recommended for men and women of all ages. Indications are it may prevent birth defects of the heart, lip and palate and have other health benefits, such as improving heart health and protecting against some cancers.

In fact, in the United States, folic acid fortification of the food supply is now mandatory, Dr. Mitchell aid, and this mandate has been followed by a 30-percent decrease in the number of pregnancies affected by neural tube defects. However, even with food supply fortification, not all women will consume an adequate amount of folic acid daily.

Doctors say one of the easiest ways to ensure that you get the daily recommended 400 micrograms (µg) of folic acid is through supplements containing the vitamin, as most U.S. multi-vitamins have the recommended amount. You also can eat a bowl of cereal with 100 percent of the daily value of folic acid per serving, Dr. Mitchell said.

Institute of Biosciences and Technology

The Texas A&M Health Science Center provides the state with health education, outreach, and research. Its five components located in communities throughout Texas are Baylor College of Dentistry, the College of Medicine, the Graduate School of Biomedical Sciences, the Institute of Biosciences and Technology and the School of Rural Public Health.

Texas A&M University System Health Science Center
2121 W. Holcombe Blvd.
Houston, TX 77030
United States

Estrogen Alone Therapy Does Not Raise Breast Cancer Risk

According to a new study by the Women's Health Initiative (WHI), therapy with just estrogen does not raise the risk of breat cancer for menopausal women. A study in 2002 into the estrogen plus progestin therapy had to be stopped when raised risks of breast cancer, blood clots, stroke and heart attack were found.

These new findings are good news for women on just estrogen therapy, say the researchers. It does not, however, help women on combined estrogen progestin therapy.

You can read about this study in JAMA (Journal of the American Medical Association), April 12 issue.

Estrogen therapy can be helpful for women with menopausal symptoms, such as hot flashes, vaginal dryness and lethargy.

(USA - Hot Flashes. UK/Ireland - Hot Flushes)

The Women's Health Initiative is a 15 year long study of diseases of older women. Results for hormone therapies have often been complicated.

Estrogen therapy alone can only be given to women who have had a hysterectomy. If a woman has a uterus she needs to take progestin to protect the uterus from the estrogen. If a woman who has uterus takes just estrogen she has a raised risk of developing uterine cancer.

The estrogen alone therapy still raises the risk of blood clots. Therefore it is recommended that a patient speak with a health care professional when comparing the benefits against the risks. Every women is different with different risk factors.

Women's Health Initiative (WHI)

Barr Withdraws FDA Application For Approval Of Extended Cycle Contraceptive Lo Seasonale

Barr Laboratories on Thursday announced it has withdrawn its FDA application for its extended-cycle oral contraceptive Lo Seasonale, Reuters reports (Reuters, 4/6). The pharmaceutical company said that discussions with FDA led them to realize that more clinical trials would be needed for Lo Seasonale -- the low-dose version of its extended-cycle oral contraceptive Seasonale -- to receive approval (AP/Houston Chronicle, 4/6). FDA approved Seasonale, which allows users to reduce their number of annual menstrual periods from 13 to four, in September 2003. Women take 84 active pills consecutively and then take seven placebo pills compared with the usual regimen of 21 active pills with seven placebos (Kaiser Daily Women's Health Policy Report, 8/22/05). Bruce Downey, chair and CEO of Barr, in a release said that the company made the "strategic decision" to withdraw the application so that it could focus on the approval of its extended-cycle oral contraceptive Seasonique, adding that the company "remain's committed to developing a franchise of extended-cycle products" (Barr Laboratories release, 4/6). Barr in August 2005 announced it received an "approvable letter" from FDA for Seasonique, which uses a 0.01 milligram dose of estrogen in place of the placebo pills (Kaiser Daily Women's Health Policy Report, 8/22/05).

Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Cialis (tadalafil) Effective In Treating Erectile Dysfunction Caused By Traumatic Spinal Cord Injury

Data presented today at the 21st Congress of the European Association of Urology (EAU) show that when patients who had erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI) were treated with Cialis® (tadalafil)(1) (N=140), their International Index of Erectile Function (IIEF) Erectile Function (EF) Domain(2) scores improved from a mean baseline score of 13.5 to a score of 22.6 at endpoint. This is compared with placebo treated patients (N=44) with a mean baseline score of 13.0 and a score of 13.6 at endpoint. It is generally considered that an improvement of 4.0 points or more in the IIEF domain score reflects a clinically meaningful change.(3) Further, 54 percent of SCI patients treated with Cialis reported "normal" erectile function at the end of the treatment phase, as measured by the IIEF EF (IIEF EF domain score greater than or equal to 26).(4)

Study Analysis and Results

The efficacy of Cialis in patients with SCI was assessed by their scores on the IIEF EF domain, responses to the Sexual Encounter Profile (SEP)(5) diary question two (successful penetration) and question three (successful intercourse), and the Global Assessment Questionnaire(6) (GAQ) question one (improved erections). Tolerability was evaluated using treatment-emergent adverse events and vital signs collected at each assessment phase in the trial.

According to SEP diary question two(7), on average, patients receiving Cialis
(N=139) reported the ability to penetrate their partner in 75.4 percent of attempts (43.6 percent at baseline). In patients receiving placebo (N=42), successful penetration was reported, on average, in 41.1 percent of attempts (44.9 percent at baseline). For SEP diary question three(8), on average, patients receiving Cialis (N=139) reported successful intercourse in 47.6 percent of attempts (10.8 percent at baseline). For patients receiving placebo (N=42), successful intercourse was reported, on average, in 16.8 percent of attempts (8.6 percent at baseline). For those patients receiving Cialis, the SEP diary questions two and three post-baseline scores were significantly different (p < 0.001) versus placebo.

According to GAQ question one (improved erections), 84.6 percent of patients (N=115) in the study reported improved erections after treatment with Cialis, whereas 19.5 percent of placebo treated patients (N=8) reported improved erections after treatment.

"Treating men for ED caused by a spinal cord injury is a complicated task. These results are encouraging for men who suffer from spinal cord injury," said Francois Giuliano, MD, PhD, Neuro-Urology Unit, Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, Garches and Medical University of Paris West, France. "Tadalafil was not only effective in improving erections, it enabled more than half the men receiving tadalafil in the trial to achieve a normal erectile function score."

Study Design

In this study, 186 patients with a mean age of 38 were randomized to receive placebo or Cialis in a double-blind, parallel, flexible-dose study in four European countries (France, Germany, Italy and Spain). Patients were treated for 12 weeks with assessments after each four-week interval.

Following a four-week, treatment-free run-in period, patients were randomized to 10 mg Cialis or placebo. After this first treatment interval, patients receiving 10 mg Cialis were either increased to 20 mg Cialis or left unchanged based on patient response to the 10 mg Cialis dose. After the second treatment interval, Cialis dosing was increased, decreased, or unchanged, based on patient response to the first treatment interval.

The study population included patients with varying degrees of SCI severity. As determined by the American Spinal Injury Association (ASIA) scale, 69.4 percent (N=186) of patients had a complete spinal cord lesion, reflecting the greatest degree of neurological impairment. Further, patients with all levels of the spinal lesion (N=179, 84.3 percent thoracic or lumbo- sacral lesions) and all degrees of erectile dysfunction (N=184, 69 percent of patients had moderate to severe ED) were included.

Study results show that Cialis improved all efficacy endpoints when compared with placebo (p < 0.001). Cialis was generally well tolerated with mild or moderate treatment-emergent adverse events. The most common treatment-emergent adverse events (greater than or equal to 5 percent incidence) were headache (8.5 percent Cialis; 4.5 percent placebo) and urinary tract infection (7.7 percent Cialis; 6.8 percent placebo). Discontinuation due to an adverse event occurred in 2.8 percent of the patients receiving tadalafil and 2.3 percent of those receiving placebo.

About ED

ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 189 million men worldwide.(9) Experts believe that 80 - 90 percent of ED cases are related to a physical or medical condition, like diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 - 20 percent are due to psychological causes.(10,11) In many cases, however, both psychological and physical factors contribute to the condition.(12)

About Cialis

Cialis® (tadalafil) was approved by the FDA in November 2003 for the treatment of erectile dysfunction. Cialis is available by prescription only and is not for everyone. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. The most common side effects with Cialis were headache, upset stomach, delayed backache or muscle ache. As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury. Men should not drink alcohol in excess with Cialis.

Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. In rare instances, men taking prescription ED tablets (including Cialis) reported a sudden decrease or loss of vision. It's not possible to determine if these events are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision, he should stop taking any ED tablet and seek immediate medical attention.

Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity. The standard recommended starting dose of Cialis for most patients is 10 mg. Patients with certain medical conditions or taking concomitant medications may need to start at a lower dose. For full patient information, visit http://www.cialis.com.

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture between ICOS Corporation (Nasdaq: ICOS) and Eli Lilly and Company (NYSE: LLY), developed tadalafil for the treatment of erectile dysfunction.

ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is working to develop treatments for serious unmet medical conditions such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer and inflammatory diseases. Additional information about ICOS is available at http://www.ICOS.com.

Vitamin C Depletion Reduces The Body's Ability To Use Fat As A Fuel Source

Too little vitamin C in the blood stream has been found to correlate with increased body fat and waist measurements. Nutrition researchers from Arizona State University report that the amount of vitamin C in the blood stream is directly related to fat oxidation - the body's ability to use fat as a fuel source - during both exercise and at rest.

Bonnie Beezhold, a graduate student in the laboratory of Dr. Carol Johnston, presented the most recent study, on the impact of vitamin C depletion on a short-term diet, on April 3 at Experimental Biology 2006 in San Francisco. The presentation was part of the scientific program of the American Society for Nutrition, Inc. (ASN).

Before beginning a controlled four-week, low-fat diet, 20 obese men and women were randomized by gender and body weight into either a Vitamin C group, taking a 500 mg vitamin C capsule daily, or a control group, taking a capsule, identical in appearance to the vitamin, containing a placebo. Neither participants nor researchers knew who was receiving which capsule until the study was over. All participants consumed a low-fat diet that the researchers adjusted individually to promote slow weight loss (about two pounds per week). The diet contained 67 percent of the USRDA (recommended daily allowance) for vitamin C (40 mg/d).

At the beginning of the clinical trial, participants with the lowest concentrations of vitamin C in their blood had the highest body fat mass and tended not to oxidize fat well compared to their less obese counterparts. As the participants moved through the four week diet, with a steady amount of vitamin C being consumed, blood vitamin C concentrations increased 30 percent in those taking vitamins and fell 27 percent in the control group whose only vitamin C intake was the 67 percent of the USRDA contained in the food. As vitamin C blood concentrations fell, so did the participants' ability to oxidize fat (an 11 percent reduction).

The highly-controlled diet worked for all participants. Although body fat mass decreased slightly more in the vitamin C group, approaching but not reaching statistical significance, both groups lost an average of nine pounds, indicating that vitamin C depletion did not appear to affect the ability to lose weight in the short term. But because the study supported early findings in Dr. Johnston's laboratory of a decrease in fat oxidation, the researchers are now studying whether the impact of vitamin C status is associated with a gradual gain in body fat in non-dieting individuals.

It is important to understand the impact of vitamin C deficiency, says Dr. Johnston, because it affects about 15 percent of adults in the United States, up from only 3-5 percent 25 years ago. She believes the increased processing of the food supply is part of the problem, since vitamin C in foods is destroyed by exposure to light, oxygen, and/or heat.

How does vitamin C affect fat oxidation and thus the risk for weight gain and obesity? Vitamin C is an essential cofactor for the biosynthesis of a small protein-like molecule known as carnitine. Carnitine functions to shuttle fat molecules to the site of fax oxidation in tissue cells. When cells do not have access to fat molecules, feelings of fatigue ensue since energy metabolism is affected. Moreover, fat tends to accumulate in tissues when carnitine concentrations are reduced.

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This research was supported by a grant from the General Mills, Bell Institute of Health and Nutrition.

Contact: Sarah Goodwin
Federation of American Societies for Experimental Biology

Vegetarian Diets Cause Major Weight Loss, New Scientific Review Shows

A scientific review in April's Nutrition Reviews shows that a vegetarian diet is highly effective for weight loss. Vegetarian populations tend to be slimmer than meat-eaters, and they experience lower rates of heart disease, diabetes, high blood pressure, and other life-threatening conditions linked to overweight and obesity. The new review, compiling data from 87 previous studies, shows the weight-loss effect does not depend on exercise or calorie-counting, and it occurs at a rate of approximately 1 pound per week.

Rates of obesity in the general population are skyrocketing, while in vegetarians, obesity prevalence ranges from 0 percent to 6 percent, note study authors Susan E. Berkow, Ph.D., C.N.S., and Neal D. Barnard, M.D., of the Physicians Committee for Responsible Medicine (PCRM).

The authors found that the body weight of both male and female vegetarians is, on average, 3 percent to 20 percent lower than that of meat-eaters. Vegetarian and vegan diets have also been put to the test in clinical studies, as the review notes. The best of these clinical studies isolated the effects of diet by keeping exercise constant. The researchers found that a low-fat vegan diet leads to weight loss of about 1 pound per week, even without additional exercise or limits on portion sizes, calories, or carbohydrates.

"Our research reveals that people can enjoy unlimited portions of high-fiber foods such as fruits, vegetables, and whole grains to achieve or maintain a healthy body weight without feeling hungry," says Dr. Berkow, the lead author.

"There is evidence that a vegan diet causes an increased calorie burn after meals, meaning plant-based foods are being used more efficiently as fuel for the body, as opposed to being stored as fat," says Dr. Barnard. Insulin sensitivity is increased by a vegan diet, allowing nutrients to more rapidly enter the cells of the body to be converted to heat rather than to fat.

Earlier this month, a team of researchers led by Tim Key of Oxford University found that meat-eaters who switched to a plant-based diet gained less weight over a period of five years. Papers reviewed by Drs. Berkow and Barnard include several published by Dr. Key and his colleagues, as well as a recent study of more than 55,000 Swedish women showing that meat-eaters are more likely to be overweight than vegetarians and vegans.

Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, especially good nutrition. PCRM also conducts clinical research studies, opposes unethical human experimentation, and promotes alternatives to animal research.

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Contact: Jeanne S. McVey
jeannem@pcrm.org
Physicians Committee for Responsible Medicine

Over 80 Percent Of US College Girls Surveyed Diet To Lose Weight

Eighty-three per cent of college girls surveyed diet to lose weight, regardless of their current body weight. A study published today in the open access journal Nutrition Journal (http://www.nutritionj.com/) also reveals that college girls practice unhealthy behaviours, such as smoking or skipping breakfast, to lose weight. By contrast, only 19% of them exercise enough to promote weight loss. The authors of the study conclude that all college girls, regardless of whether they are normal weight, overweight or obese, would benefit from counselling or open discussions about healthy dieting practices.

Brenda Malinauskas and colleagues from East Carolina University, Greenville, USA asked 185 college girls about their weight perception, dieting practices and physical activity.

Malinauskas et al. found that 83% of the girls reported trying to control their weight or having tried to control their weight, regardless of whether they were normal weight, overweight or obese. Of the 185 girls studied, 80% reported exercising to lose weight although 32% did not really take part in regular physical activity and only 19% of them actually exercised often and vigorously enough to lose weight. Eating low fat, low sugar foods, eating less than one wants and counting calories were other methods used to lose weight. The most maladaptive weight loss practice reported was smoking to lose weight - it was reported by 9% of the girls. The most unhealthy practice reported was skipping breakfast - reported by 32% of the girls.

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Article:
Dieting practices, weight perceptions, and body composition: A comparison of normal weight, overweight, and obese college females Brenda M Malinauskas, Thomas D Raedeke, Victor G Aeby, Jean L Smith and Matthew B Dallas Nutrition Journal (in press)

Contact: Juliette Savin
juliette.savin@biomedcentral.com
BioMed Central

Evidence Of Estrogen And Progesterone Hormone Allergy Has Been Discovered By Texas Researchers

Some women with menstrual cycle disorders like asthma and migraine headaches may be experiencing allergies to their own estrogen and progesterone hormones, Texas researchers have discovered.

Russell Roby, M.D., director of the Roby Institute, Dr. Dick Richardson, professor at The University of Texas at Austin, and Dr. Aristo Vojdani, of Immunosciences Lab, Inc. in California, found that female patients who experienced health changes during their menstrual cycle had higher levels of IgE antibodies against progesterone and estrogen than control subjects. An increase in IgE antibodies is typically associated with allergic response.

The researchers published their findings in the March issue of the American Journal of Reproductive Immunology.

"This is going to explain a lot of unexplained illnesses," says Roby, alumnus of The University of Texas at Austin. "The primary disorders are premenstrual asthma, menstrual migraines, interstitial cystitis and fibromyalgia. We have no idea what causes these things, but they are definitely linked to hormonal cycles."

The researchers studied blood samples from healthy women and women who experienced symptoms associated with their menstrual cycles, like asthma, migraines and joint pain. A significant number of patients in the latter group showed high levels of IgG, IgM and IgE antibodies against estrogen and progesterone.

Antibodies play a critical role in immune response and are produced by the body in response to antigens, molecules the body recognizes as foreign.

Hormones haven't been implicated in allergic response in the past, because it was thought that hormone molecules were too small to create an allergic response. The researchers found that estrogen and progesterone combine with other proteins and that the hormone part of the molecular complex is recognized as the antigen.

"We have shown that IgE antibodies, Type 1-immediate allergy antibodies, are produced against estrogen and progesterone," says Roby. "This opens a whole new area of treatment possibilities."

Roby says that in the process of the clinical study, it was found that symptoms could be diminished by very low concentrations of progesterone, which served both as a diagnostic feature and for symptomatic relief when needed.

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Contact: Russell R. Roby, M.D.
roby@drroby.com
University of Texas at Austin